
Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110
The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not...
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The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not...

Ingredients statement declares Anchovy and Sasame, but Contains statement does not declare Fish (Anchovy) and Sesame.

The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version...

It was identified that certain devices were being operated outside the validated and FDA-cleared display...

Potential for detachment of a distal tip component of the device during use.

Potential for detachment of a distal tip component of the device during use.

Potential for detachment of a distal tip component of the device during use.

Potential for detachment of a distal tip component of the device during use.

Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.

High sugar content. The firm was notified by the FDA that sample results were positive for a high C4 sugar content.

Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK...

Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK...

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants

CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.

This recall is being initiated following FDA's recommendation based on certain observations noted during an August...

This recall is being initiated following FDA's recommendation based on certain observations noted during an August...

This recall is being initiated following FDA's recommendation based on certain observations noted during an August...

This recall is being initiated following FDA's recommendation based on certain observations noted during an August...

This recall is being initiated following FDA's recommendation based on certain observations noted during an August...

This recall is being initiated following FDA's recommendation based on certain observations noted during an August...

This recall is being initiated following FDA's recommendation based on certain observations noted during an August...

This recall is being initiated following FDA's recommendation based on certain observations noted during an August...

This recall is being initiated following FDA's recommendation based on certain observations noted during an August...

This recall is being initiated following FDA's recommendation based on certain observations noted during an August...

This recall is being initiated following FDA's recommendation based on certain observations noted during an August...

This recall is being initiated following FDA's recommendation based on certain observations noted during an August...

This recall is being initiated following FDA's recommendation based on certain observations noted during an August...

This recall is being initiated following FDA's recommendation based on certain observations noted during an August...

This recall is being initiated following FDA's recommendation based on certain observations noted during an August...

Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which...

Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the...

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the...

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the...

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the...

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the...

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the...

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the...

Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of...

Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of...

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
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